Kinnate Biopharma Inc. to Report First Clinical Data for Its Investigational Pan-RAF Inhibitor, Exarafenib (KIN-2787), in an Oral Presentation at the AACR 2023 Annual Meeting


  • Company has initiated enrollment of patients into the monotherapy expansion cohorts

  • Company to host a virtual investor webcast on April 17, 2023, to discuss the AACR results and dose expansion strategy, and to provide additional pipeline updates

SAN FRANCISCO and SAN DIEGO, March 14, 2023 (GLOBE NEWSWIRE) -- Kinnate Biopharma Inc. (Nasdaq: KNTE) (“Kinnate”), a clinical-stage precision oncology company, today announced that a clinical trial abstract for its investigational pan-RAF inhibitor exarafenib has been selected for an oral presentation during the Clinical Trials Mini Symposium Session at the American Association for Cancer Research (AACR) 2023 Annual Meeting, being held April 14-19 in Orlando, Fla.

The oral presentation represents the first report of safety and clinical efficacy data from the monotherapy dose escalation portion of KN-8701, an ongoing global Phase 1 clinical trial evaluating exarafenib in patients with BRAF-altered solid tumors and NRAS mutant-positive melanoma.

The company also announced that it has initiated enrollment of patients into the monotherapy dose expansion cohorts of KN-8701 and will discuss the expansion strategy, along with results of the AACR presentation and additional pipeline updates, during a virtual investor webcast on April 17, 2023 at 5:30 p.m. ET

“Kinnate’s presence at AACR this year represents the first clinical data release from the company and underscores the rapid progress we are making through our discovery engine for those battling cancer,” said Nima Farzan, chief executive officer, Kinnate Biopharma Inc. “We look forward to coming together with the scientific community to share monotherapy results on exarafenib, a novel, potentially first-in-class pan-RAF inhibitor. Our extensive preclinical work shows compelling data for exarafenib as a highly selective pan-RAF with broad potential in cancers that harbor BRAF alterations, including in BRAF Class II and Class III where targeted therapies have had limited success.”

Separately, new preclinical data for exarafenib monotherapy and in combination with a MEK inhibitor in human NRAS mutant melanoma models will be presented in a poster session.

Kinnate Presentations at AACR 2023

Title: A Global Phase 1 Clinical Trial Evaluating Exarafenib Monotherapy (KIN-2787), a Highly Selective Pan-RAF Inhibitor, in BRAF-Altered Solid Tumors and NRAS Mutant Melanoma
Author: Alexander Spira, MD, PhD, FACP, Virginia Cancer Specialists Research Institute
Abstract Number: 9851
Session Category: Clinical Trials Mini Symposium
Session Date and Time: April 17, 2023, 3:35 p.m. - 3:45 p.m. ET
Session Location: Chapin Theater - Convention Center

The AACR website indicates that clinical trial abstracts will be published on April 14, 2023 at 12:00 p.m. ET, at which time Kinnate will also make the abstract available under the Presentations and Publications section of Kinnate.com. The company intends to present an updated data cut with additional patients and follow-up during the oral presentation on April 17. Kinnate will post the presentation slides on April 17 at the same website.

Title: Exarafenib (KIN-2787) is a Potent, Selective Pan-RAF Inhibitor with Activity in Preclinical Models of BRAF Class II/III Mutant and NRAS Mutant Melanoma
Author: Nichol Miller, PhD
Abstract Number: 4927
Poster Board Number: 5
Session Category: Experimental and Molecular Therapeutics
Session Date and Time: Tuesday April 18, 2023 1:30 p.m. - 5:00 p.m. ET

Kinnate will host an exhibit at the AACR 2023 Annual Meeting at booth number 1725.

For additional information, visit the AACR Meeting webpage: https://www.aacr.org/meeting/aacr-annual-meeting-2023/.

Virtual Investor Webcast Information

Kinnate will host a webcast on Monday, April 17, 2023 at 5:30 p.m. ET. Investors and the general public are invited to listen to a live webcast of the session through the "Investors and Media" section on Kinnate.com or by dialing the U.S. toll free number +1-888-256-1007 and entering confirmation code: 7465233. An archived edition of the session will be available following the event.

About Exarafenib

Exarafenib is an orally administered, potent and selective investigational small molecule pan-RAF inhibitor. Unlike currently available treatments that target only Class I BRAF kinase mutations, exarafenib is designed to target BRAF Class II and Class III alterations, where it has the potential to be a first-line targeted therapy, in addition to covering BRAF Class I alterations, and as a potential treatment for NRAS mutation-positive melanoma. 

KN-8701 Clinical Trial Background

KN-8701 is an ongoing, global Phase 1 clinical trial (NCT04913285) evaluating exarafenib in patients with advanced solid tumors harboring BRAF Class I, II and III alterations, and/or who have NRAS mutant melanoma. The trial is enrolling patients at more than 35 sites across the globe. KN-8701 contains a two-part dose escalation: Part A1 evaluates exarafenib as a monotherapy across BRAF alterations and tumor types and Part A2 is evaluating exarafenib in combination with binimetinib, a MEK inhibitor. Part B, the dose expansion phase, is evaluating exarafenib at the recommended dose and schedule in patients with BRAF-altered cancers including lung cancer, melanoma and other solid tumors.

About Kinnate Biopharma Inc.

Kinnate Biopharma Inc. is a clinical-stage precision oncology company focused on expanding on the promise of targeted therapies for those battling cancer. The company is developing medicines for known oncogenic drivers where there are no approved targeted drugs and to overcome the limitations of marketed cancer therapies, such as non-responsiveness or acquired and intrinsic resistance. Kinnate has two lead clinical programs being studied in solid tumors with RAF, NRAS and FGFR-driven alterations, and is rapidly progressing a pipeline of additional small molecule drug candidates as part of the Kinnate Discovery Engine. The company is driven by the urgency and knowledge that patients are waiting for new, effective cancer medicines.  For more information, visit Kinnate.com and follow us on LinkedIn.

Forward-Looking Statements

This press release contains forward-looking statements that involve substantial risks and uncertainties. These forward-looking statements include, without limitation, statements regarding the potential benefits of exarafenib; our intention to make an oral presentation of exarafenib clinical data (including updated data not contained in the abstract), present a poster session of exarafenib preclinical data, host an exhibit booth at AACR, host a virtual investor webcast and provide additional pipeline updates; and statements by our Chief Executive Officer. Words such as “believes,” “anticipates,” “plans,” “expects,” “intends,” “remain,” “will,” “goal,” “potential” and similar expressions are also intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events and trends. Such expectations and projections may never materialize or may prove to be incorrect. These forward-looking statements are subject to a number of risks, uncertainties, assumptions and other factors, including recently transitioning to operating as a clinical-stage biopharmaceutical company with a limited operating history; the timing, progress and results of ongoing and planned preclinical studies and clinical trials for our current product candidates; that our assessment that initial responses from KN-8701 are encouraging will bear out over time; that continued dose escalation in our clinical trials could increase the risk of the occurrence of adverse events; the potential for future clinical trial results to differ from initial results or from our preclinical studies; our ability to timely enroll a sufficient number of patients in our clinical trials; our ability to raise additional capital to finance our operations; our ability to discover, advance through the preclinical and clinical development of, obtain regulatory approval for and commercialize our product candidates; the novel approach we are taking to discover and develop drugs; our ability to timely file and obtain approval of investigational new drug applications for our planned clinical trials; negative impacts of the COVID-19 pandemic on our business, including ongoing and planned clinical trials and preclinical studies; competition in our industry; regulatory developments in the United States and other countries; our ability to attract, hire and retain highly skilled executive officers and employees; difficulties in managing our growth; our ability to protect our intellectual property; reliance on third parties to conduct our ongoing and planned preclinical studies and clinical trials, and to manufacture our product candidates; general economic and market conditions; and other risks. These and other risks, uncertainties, assumptions and other factors are further described under the heading “Risk Factors” in our Quarterly Report on Form 10-Q for the quarterly period ended September 30, 2022 that we have filed with the Securities and Exchange Commission (“SEC”), as well as in our subsequent filings we make with the SEC. New risk factors emerge from time to time and it is not possible for our management to predict all risk factors, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in, or implied by, any forward-looking statements. Investors should not rely upon forward-looking statements as predictions of future events. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements. Our forward-looking statements speak only as of the date of this release, and except as required by law, we undertake no obligation to update publicly any forward-looking statements for any reason in the future.

Investor & Media Contact:

Priyanka Shah | Priyanka.Shah@kinnate.com | +1-908-447-6134